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Clinical and Radiological Results of Long Term Tibial and Femoral Osteotomy in Knee Ostheoarthritis With Concomitant Lower Limb Malalignement (KNEE OSTEOTOMY)

I

Istituto Ortopedico Rizzoli

Status

Enrolling

Conditions

Malalignment, Bone
Knee Osteoarthritis

Treatments

Other: High tibial osteotomy

Study type

Observational

Funder types

Other

Identifiers

NCT06462625
KNEE OSTEOTOMY-OA

Details and patient eligibility

About

The present study aims to evaluate the long-term and medium-term outcomes of different knee osteotomy techniques in the treatment of knee osteoarthritis in patients with lower limb malalignment. This evaluation is necessary in the current context of research on the treatment and prevention of knee osteoarthritis through treatments that do not involve or allow for the postponement of prosthetic replacement. Among the biological treatments performed in orthopedic clinical practice, osteotomy is one of the most promising. However, further long-term evaluations are needed to more clearly determine the indications and potential of this type of intervention, considering the various surgical procedures described for performing it.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Patients undergoing corrective knee osteotomy and any associated procedures such as meniscal repair/resection/replacement, ligament reconstruction, chondral treatment, or regenerative infiltrative treatment;
  2. Patients aged between 18 and 70 years at the time of surgical intervention;
  3. Patients with isolated compartmental osteoarthritis;
  4. Patients with a varus or valgus knee alignment defect of at least 3° compared to mechanical neutrality.

Exclusion criteria

  1. Patients with advanced multicompartimental osteoarthritis;
  2. Patients who are no longer reachable;
  3. Women of childbearing age who cannot exclude pregnancy;
  4. Patients unable to give informed consent or patients unwilling to sign the informed consent form.

Trial design

150 participants in 2 patient groups

Closing wedge
Description:
Patients undergoing closing wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement
Treatment:
Other: High tibial osteotomy
Opening wedge
Description:
Patients undergoing opening wedge high tibial osteotomy in knee ostheoarthritis and lower limb malalignement
Treatment:
Other: High tibial osteotomy

Trial contacts and locations

1

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Central trial contact

Stefano Zaffagnini

Data sourced from clinicaltrials.gov

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